# K040111: Zeus Scientific, Inc., Athena Multi-Lyte Mpo/PR3 Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Apr 5, 2004 after 76 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K261466: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM (2026), 0 descendants of its own

## Indications for use
The Zeus Scientific, Inc. AtheNA Multi-Lyte T M MPO/PR3 Test System is for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and/or human proteinase 3 (PR3) in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of systemic vasculitides (SV). This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K040111
Methodology: https://510kreport.com/methodology